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CTRI Number  CTRI/2023/01/048789 [Registered on: 06/01/2023] Trial Registered Prospectively
Last Modified On: 27/12/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   Indications and outcomes of cirrhosis and acute on chronic liver failure patients undergoing liver transplantation 
Scientific Title of Study   Liver transplantation in patients with CirrHosis and severe Acute-on-Chronic Liver Failure (ACLF): iNdications and outComEs (CHANCE) Study on behalf of the EASL-CLIF Consortium 
Trial Acronym  CHANCE 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT04613921  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shiran Shetty  
Designation  Professor and Head 
Affiliation  Kasturba Medical college 
Address  Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  8861920517  
Fax    
Email  shiran.shetty@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Shiran Shetty  
Designation  Professor and Head 
Affiliation  Kasturba Medical college 
Address  Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  8861920517  
Fax    
Email  shiran.shetty@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Shiran Shetty  
Designation  Professor and Head 
Affiliation  Kasturba Medical college 
Address  Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  8861920517  
Fax    
Email  shiran.shetty@manipal.edu  
 
Source of Monetary or Material Support  
European Foundation for the Study of Chronic Liver Failure, Travessera de Gràcia, 11, 7th floor, 08021 Barcelona (Spain) 
 
Primary Sponsor  
Name  European Foundation for the Study of Chronic Liver Failure 
Address  Travessera de Gràcia, 11, 7th floor, 08021 Barcelona, Spain 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Australia
France
Germany
India
Netherlands
Spain
Turkey
United Kingdom
United States of America  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shiran Shetty  Kasturba Hospital  Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal, Karnataka- 576104
Udupi
KARNATAKA 		 8861920517

shiran.shetty@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba medical college and Kasturba Hospital Institutional ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K72||Hepatic failure, not elsewhere classified, (2) ICD-10 Condition: K744||Secondary biliary cirrhosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Subjects with the diagnosis of liver cirrhosis
2. subjects who have been hospitalized for acute decomposition of liver cirrhosis and referred to the transplant team
3. Patients who have been informed and signed for informed consent  
 
ExclusionCriteria 
Details  1. Acute or subacute liver failure without underlying cirrhosis
2. Patients with hepatocellular carcinoma outside Milan criteria or other active neoplasia
3. Subjects listed for transplantation other than the liver or liver-kidney transplant
4. Subjects with previous liver transplantation
5. Vulnerable population
6. Pregnant and/ or breastfeeding women
Patients who cannot provide prior informed consent
7. Patients and team not committed to providing intensive care if needed
8. Patients with relevant comorbidities that could impact the prognosis:
Subjects with very severe hepatopulmonary syndrome
subjects with severe pulmonary disease obstructive lung disease
subjects with chronic kidney disease requiring hemodialysis
subjects with severe heart disease
subjects with known infection with HIV
subjects with neurological or psychiatric disorders 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the 1-year graft and patient survival rate after liver transplant (LT) in ACLF 2/3 with patients with decompensated cirrhosis with ACLF 2 and 3  0,3,6,9,12 months  
 
Secondary Outcome  
Outcome  TimePoints 
To identify factors in decision-making for listing patients with severe ACLF to transplant team
To compare the clinical course of patients with ACLF2/3 with decompensated cirrhosis without ACLF 2/3
To identify predictive factors of death or delisting on the waiting list for patients with ACLF 2 and 3
To identify predictive factors for death after LT
To identify and compare post-LT survival rate and Quality of life in patients with ACLF 2/3 with patients with decompensated cirrhosis without ACLF 2/3 		 0,3,6,9,12 months  
 
Target Sample Size   Total Sample Size="3000"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/01/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  08/07/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation (LT) as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximizing LT success. Alternative strategies, such as living-donor LT, should be explored. LDLT has impressive results in Eastern centers, but it is restrained in Western countries, due to potentially life-threatening complications in the donor.

 
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